Immune Monitoring (Accredited)

Programme objective: To assess a laboratory’s ability to calculate the absolute count (cells/µL) and percentage of lymphocyte subsets using flow cytometry.

Clinical/scientific background: The enumeration of lymphocyte subsets is important in a variety of conditions such as primary immunodeficiency (e.g. Severe Combined Immunodeficiency / SCID) or the monitoring of drug therapies such as rituximab in autoimmune disorders. However, the most common use is in the monitoring of Human Immunodeficiency Virus / HIV, a secondary immunodeficiency disorder.

Suitability: Participation in this External Quality Assessment (EQA) programme is open to laboratories employing any Flow Cytometric approach for the identification and enumeration of lymphocyte subsets in a sample.

Samples are suitable for use with whole blood lysis techniques and sequential gating strategies. Laboratories are requested to report both percentage and absolute values (in cells per microlitre), and performance is monitored using this data, unless a centre chooses to eschew either parameter in which case they would not be performance monitored for the relevant parameters. Non-flow cytometric systems and those that include electronic volume measurement to identify cells will be scored as separate cohorts to allow for the performance monitoring of these systems.

All EQA programme communications, data entry, and reports will be conducted exclusively in the English language. Participants must ensure proficiency in English to fully engage in the programme.

The programme welcomes participation from diverse sectors including:

Clinical Healthcare Laboratories
Academic and Research Institutions
In Vitro Diagnostics (IVD) Manufacturers
Pharmaceutical companies

Minimum participation level 30, maximum participation level 1200.

Sample type/distribution: To ensure that the programme meets the requirements of all users the programme issues stabilised whole blood with laboratories required to determine the lymphocyte subsets (CD3+, CD3+/CD4+, CD3+/CD8+, CD19+ and CD16+/56+). The programme issues 2 samples per trial and trials are issued a minimum of 4 and a maximum of 6 times a year

Trial duration: Trials for this programme are live/open for a minimum of three weeks. Please note trials issued/closing in August or December are extended by one week. An automated email is sent two days prior to the trial closing, to any participant that has not returned results, warning them of the trial closure date.

Subcontracted areas: No activities in relation to this EQA programme are subcontracted.

Updates to the programme for current or upcoming year: As part of our commitment to develop the External Quality Assessment (EQA) programmes provided by this centre we are in the process of developing the Immune Monitoring Programme to incorporate a wider selection of tests. Any further updates will be communicated to participants.

Each year we quote a minimum and a maximum number of possible trial distributions that will be issued on our website, subject to sample availability. Historically, we have consistently achieved the maximum number of distributions. In 2025-2026 due to staffing shortage, we are unlikely to hit the maximum number of distributions, as we have in previous years and trials may not be equally distributed throughout the year i.e; bimonthly. We will return to the full trial distribution schedule in 2026-2027. Please accept our apologies for this short-term decrease in our services.

To register for this programme, please click here.